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EndoPilot Obtura set

FDA UDI

Class I (US FDA UDI)

by Schlumbohm GmbH & Co. KG

Identity

Trade Name
EndoPilot Obtura set FDA UDI
Generic Name
Endodontic obturation system FDA UDI
Device Name
EndoPilot Obtura expansion set consist of: 1x BackFill Gun Obtura, 1x Obtura Needle Lock Nut, 4x Heat Insulator, 5x Gun-Needle Ø 25 ga, 100x Gutta Percha Bar, Accessory tools FDA UDI
Model / Reference
v01 FDA UDI
Description
EndoPilot Obtura expansion set consist of: 1x BackFill Gun Obtura, 1x Obtura Needle Lock Nut, 4x Heat Insulator, 5x Gun-Needle Ø 25 ga, 100x Gutta Percha Bar, Accessory tools FDA UDI

Identifiers

Catalog Number
110 0133-US FDA UDI
Primary DI / UDI-DI
04260482991128 FDA UDI
FDA Product Code
EKR FDA UDI
EKM FDA UDI
GMDN Term
Endodontic obturation system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
872.3850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Synthetic gutta-perchaEndodontic obturation system

EndoPilot Obtura set by Schlumbohm GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endodontic obturation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Schlumbohm GmbH & Co. KG

Sources (1)

  • FDA UDI 2717147a-6182-4bbc-995d-870c39956645 34 fields · synced May 30, 2026